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Company description

AssurX develops enterprise quality management and regulatory compliance software for organizations across life sciences, energy, and other regulated industries. The platform consolidates all quality and compliance processes into a single configurable system, replacing paper-based or fragmented legacy applications with a unified electronic environment. AssurX serves a broad range of customers worldwide, including pharmaceutical manufacturers, combination product makers, CDMOs, cosmetics companies, dietary supplement brands, and academic health systems such as Duke University Health.

The AssurX platform is designed to be deployed incrementally — organizations can implement the modules they need immediately and add more over time. All solutions come pre-validated with complete documentation, which is intended to reduce deployment risk and save time. The system supports integration with other software solutions to eliminate data silos, and its pre-configured workflows are available from day one.

Quality Management Modules

• CAPA Management: Tracks and manages corrective and preventive actions across the organization.
• Audit Management: Manages internal and external audit planning, execution, and follow-up.
• Document Management: Digitizes and organizes controlled documents and records.
• Training Management: Tracks employee training requirements and completion.
• Change Management: Controls and documents changes to processes, products, and systems.
• Complaint Management: Captures and manages customer complaints through resolution.
• Nonconformance Management: Records and addresses product or process nonconformances.
• Deviation Management: Manages deviations from established procedures or specifications.
• Supplier Quality Management: Monitors and manages supplier quality performance and compliance.
• Customer Quality Management: Handles quality-related interactions and issues on the customer side.
• Risk Management: Identifies, assesses, and mitigates quality and compliance risks.
• Calibration Management: Tracks equipment calibration schedules and records.
• EHS Incident Management: Records and manages environmental, health, and safety incidents.
• Quality Management Review: Supports periodic management review processes.
• Validation Management Solution: Manages validation activities and associated documentation.

Enterprise Energy Compliance System (ECOS)

• A separate, process-driven compliance system designed for the energy sector.
• Manages NERC and regional compliance standards.
• Uses risk-driven internal controls and configurable workflows to support secure compliance operations.

Platform Capabilities and Deployment

• All quality and compliance processes are included within the core platform, removing the need to purchase and install separate individual modules.
• Pre-configured workflows are available from initial deployment, supporting a smooth transition from paper-based or manual systems.
• The system is designed for easy configuration, modification, and integration with third-party software solutions.
• Data is stored in a searchable format to support efficient information retrieval and management.
• All solutions are pre-validated and delivered with complete documentation to reduce implementation risk.
• The platform supports integration with existing enterprise software to unify data across the organization.

Notable Customer Outcomes

• A pharmaceutical manufacturer that had been running four separate, poorly integrated quality applications consolidated onto AssurX, deploying 16 processes in priority order. Reported first-year results included a 65% reduction in server maintenance costs, a 90% reduction in licensing costs, a reduction of 3,072 personnel hours, and total hard cost savings of $266,000.
• Duke University Health replaced a legacy QMS originally implemented around 2005 that had become inadequate as the QADVIP team's portfolio of labs and projects grew in size and complexity.
• Xyngular adopted AssurX after outgrowing a manual quality management system as the company expanded.
• EyePoint Pharmaceuticals, regulated as both a combination product manufacturer and a CDMO, replaced paper-based processes with AssurX to improve productivity and visibility across the quality chain.
• Goodier Cosmetics transitioned from a manual QMS to AssurX to meet quality management compliance requirements in the skincare industry.

AssurX positions its platform as a single, adaptable system capable of supporting the full range of quality and compliance requirements across regulated industries, with a deployment model that allows organizations to start with immediate needs and expand usage over time as requirements evolve.

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Software attributed to AssurX

• VMSView
• AutoValidatorView
• eMDRView

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